Biotechnology Research in an Age of Terrorism (2004) / Chapter Skim
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1. Introduction
1. Introduction
Pages 15-40
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chemical, nuclear, or biological. In early 1992, President Yeltsin acknowledged that, despite being an original signatory and State party to the Biological and Toxin Weapons Convention (BWC)
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programs linked to biological weapons have been restricted to research and development on defensive measures only. Thus few biologists in the United States today have knowledge of our country's past offensive weapons programs or of the concerns of the national security branches of government.
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. Biotechnology research is now a truly global enterprise.
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According to Medline, the total number of scientific articles published in the peer-reviewed biomedical literature increased from 449,109 in 1998 to 491,620 in 2001. Given the global nature of the biotechnology research and development enterprise, it is unrealistic to think that biological technologies and the knowledge base upon which they rest can somehow be isolated within the borders of a few countries.
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But many of the same methods for developing attenuated live vaccines against viral diseases can have offensive applications as well.~4 The key issue is whether the risks associated with misuse can be reduced while still enabling critical research to go forward. A BRIEF HISTORY OF MODERN BIOLOGICAL WARFARE Of thousands of species of potentially pathogenic microorganisms, very few have been developed and deployed as biological weapons.
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At least 700 Chinese reportedly died from plague alone,~9 although the number of Chinese civilians killed between 1933 and 1945 by Japanese germ warfare may be much higher.20 lapan's secret biological warfare program, Unit 731,2~ officially referred to as the Army Anti-Epidemic Prevention and Water Supply Unit, was located in a remote, high-security area in lapanese-occupied Manchuria, first in Harbin and then in Ping Fan. The Japanese perfected culture and dispersal techniques for a large number of biological agents.
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, utilizing a variety of human, animal, and plant pathogens.25 "Between 1941 [sic] and 1969, the policy of the United States regarding biological warfare was first (to)
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The explosion in biotechnologies and genetic engineering technologies all of which have legitimate civilian applications could empower a hostile agent. Gordon Oehler, director of the Non-Proliferation Center at the Central Intelligence Agency, testified before the Senate Armed Services Committee on March 27, 1996, and stated that there was "a continuing pursuit by many countries to acquire chemical and biological weapons and that The chilling reality is that these materials and technologies are more accessible now than at any other time in history."33
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The contrast between what is a legitimate, perhaps compelling subject for research and what might justifiably be prohibited or tightly controlled cannot be made a priori, stated in categorical terms, nor confirmed by remote observation. Matthew Meselson, a leading molecular biologist, gave a stark warning of the potential dangers posed by the destructive applications of biotechnology in May 2000: Every major technology metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy has been intensively exploited, not only for peaceful purposes but also for hostile ones.
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recently released research priorities for countering bioterrorism identified several categories of research activities in immunology and genomics that would be considered "provocative" if conducted by a hostile or rogue government. These include efforts to "identify pathogen-induced immunoregulatory and immunosuppressive effects" as well as to "analyze gene expression of agents of bioterrorism."40 John Cannon, former chairman of the National Intelligence Council and a former deputy director for intelligence at the CIA, observed that "the continuing revolution in science and technology will accentuate the dual use problem related to biotech breakthroughs in biomedical engineering, genomic profiling, genetic modification, and drug development....
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The authors subsequently sought to alter the ectromelia by adding an immunomodulator with the hope that this would increase the immune response of the infected mice to their fertilized eggs and thus make them permanently infertile. They drew upon previous published work by others with recombinant vaccinia virus in mice in which it had been shown that incorporating the gene for the immunomodulatory cytokine IL-4 into the viral genome and thus overexpressing it in vivo enhanced the virulence of vaccinia virus in mice.
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The authors of this study, therefore, were building upon an established literature in this field that is filled with similar findings on the effects of the decreased or increased levels of IL-4 and other immunomodulatory factors on the virulence of other viruses and many microorganisms. As previously noted, the design of the mousepox study built upon previously published studies in which vaccinia virus engineered to express IL-4 was studied in mice.
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Finally, it is worth noting that this work was done outside the United States and could have been published in an Australian or European journal, illustrating the limits of national policies to address dual use concerns and, in this case specifically, the need to have international guidelines for the publication of manuscripts containing "sensitive" information. Total Synthesis of the Poliovirus Genome and Recovery of Infectious Titus Wimmer and colleagues46 reported that they had reconstructed poliovirus from chemically synthesized oligonucleotides that were linked together and then transfected into cells.
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The Weldon resolution also called upon the Executive Branch to "examine all policies, including national security directives, relevant to the classification or publication of federally-funded research to ensure that, although the free exchange of information is encouraged, information that could be useful in the development of chemical, biological, or nuclear weapons is not made accessible to terrorists or countries of proliferation concern."47 Many scientists concluded that the Wimmer experiment was neither a novel discovery nor a potential threat. The general principle that one could make live poliovirus from a DNA template was already known in 1981, when Baltimore and colleagues48 reported that a DNA copy of the positive strand RNA genome of poliovirus could be taken up into living cells under appropriate conditions and result in the generation of encapsulated, infectious virus.
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Both viruses have an inhibitor of immune response enzymes vaccinia virus complement control protein (VCP) and smallpox inhibitor of complement enzymes (SPICE)
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There have been no reported cases of disease caused by recombinant microorganisms despite the widespread use of gene splicing techniques in academic laboratories and in the production of pharmaceuticals. In view of this experience, and the prospects for understanding the etiology of complex diseases and finding cures for them, the NIH has revised its Guidelines several times, with the net result being the elimination of the earlier prohibitions and the exemption from the Guidelines of essentially all recombinant DNA experiments except those that involve the molecular manipulation of human and restricted animal and plant pathogens.
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The challenge to the scientific community, therefore, is to develop formal and informal processes and procedures to mitigate or minimize the destructive applications of advanced biotechnology without unduly restricting legitimate biotechnology research activities. Beginning the process of addressing these challenges is the purpose of this study.
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capacity to prevent the destructive application of biotechnology research while still enabling legitimate research to be conducted. This report is part of a larger body of work that The National Academies have undertaken in recent decades on science and security issues, beginning with Scientific Communication and National Security in 1982 and continuing into the 1990s with the publication of Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response (1999)
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An additional impetus for the Committee's consideration of information control regimes for unclassified research in the life sciences was the announcement by the White House shortly before the Committee's first meeting of its renewed interest in the application of "sensitive but unclassified information" control regimes for managing the dissemination of unclassified research that is financed by the federal government.56 Report Road Map Chapter 2 reviews the current domestic and international rules, regulations, and institutional arrangements and processes that provide oversight of research on pathogens and potentially dangerous biotechnology research within government laboratories, universities and other research institutions, and industry. Chapter 3 reviews the existing and emerging regulatory environment governing the control of information related to biological research.
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It is usually reported62 that the fleeing Genoese brought the Black Death with them via plague-infested rodents, along shipping routes to Sicily, Sardinia, Corsica, and Genoa and from there it spread overland throughout Italy and Europe. It is considered equally likely, however, that the entry of plague into Europe from the Crimea occurred independent of this event.63 Over a four-year period, the plague eventually caused 25 million deaths one-third of Europe's population at the time.
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An "interim progress report" on the search for banned weapons of mass destruction in Iraq released on October 2, 2003 revealed no stockpiles of such weapons, though it did cite "rudimentary" traces of weapons programs, concealed equipment, and so forth. A copy of the unclassified statement, presented by David Kay and made available by the CIA, may be found at: http://www.fas.org/irp/cia/product/dkaylO0203.html.
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2003. "The history of biological warfare: Human experimentation, modern nightmares, and lone men in the twentieth century," EMBO Reports 4 (special issue)
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1947. "Biological Warfare Research in the United States" in History of the Chemical Warfare Service in World War II (1 July 1940 - 15 August 1945)
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2001. "Controlling biological warfare threats: Resolving potential tensions among the research community, industry, and the national security community," Critical Reviews in Microbiology, 27~4~:321-354.
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2003. "The history of biological warfare: Human experimentation, modern nightmares, and lone madmen in the twentieth century," EMBO Reports 4 (special issue)
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2000. "Biological warfare in eighteenth century America: Beyond leffrey Amherst." Journal of American History 86:1552-1558, and Fenn, E.A.
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